UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011554 |
|---|---|
| Receipt number | R000012507 |
| Scientific Title | Effect of duloxetine and vitamin B12 on pain and numbness with chemotherapy-induced neuropathy |
| Date of disclosure of the study information | 2013/08/22 |
| Last modified on | 2015/03/20 15:00:17 |
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Basic information
Public title
Effect of duloxetine and vitamin B12 on pain and numbness with chemotherapy-induced neuropathy
Acronym
duloxetine on chemotherapy-induced neuropathy
Scientific Title
Effect of duloxetine and vitamin B12 on pain and numbness with chemotherapy-induced neuropathy
Scientific Title:Acronym
duloxetine on chemotherapy-induced neuropathy
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We randomize the patients with neuropathy by cancer drugs and administer vitamin B12 and duloxetine or reverse order, and evaluate the symptom reduction by these drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
numbness and pain (VAS)
Key secondary outcomes
neurological symptoms (CTCAE)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
one week duloxetine 20mg/day (loading dose), three weeks duloxetine 40 mg /day, 2~4 weeks washout period and four weeks vitamin 12 1500mg/day
Interventions/Control_2
reverse order
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients who were administered vincristine, paclitaxel, docetaxel, bortezomib or oxaliplatine and feel neuropathic pain or numbness (in or outpatients)
Key exclusion criteria
1) bad controlled liver, kidney, heart, lung , hypertension and infectious diseases
2) psychiatric diseases including depression
3) pregnancy or breast-feeding
4) intake MAO inhibitor (contraindication with duloxetine)
5) the cases whom the doctor decide not to be the indication
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Hirayama |
Organization
Higashi Sapporo Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
Shiroishiku Higashisapporo 3-3, Sapporo
TEL
011-812-2311
hirayama@hsh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Hirayama |
Organization
Higashi Sapporo Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
Shiroishiku Higashisapporo 3-3, Sapporo
TEL
011-812-2311
Homepage URL
hirayama@hsh.or.jp
Sponsor or person
Institute
Higashi Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
Higashi Sapporo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012507
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
